Imagine being the CEO of a small med-tech company with a surefire product and nearly $35 million in venture capital. The company is all set to get the green light from the FDA and start clinical trials. Then it happens. The FDA throws the company a curveball and says that the technology the company is appropriating isn't something they've dealt with before and they're not quite so sure how to evaluate it. The chances of a 510(k) diminish and a PMA seems to be the only option.
It's a scenario that small startup Luminous (Carlsbad, California) faced when it went to get approval for its automated glucose monitor. Previously, Luminous was planning to use a sensing technology based on near-infrared spectrometry. Infrared spectrometry was untested waters when it came to using a glucose monitor, so that's where the issue came with the FDA, the company said.
"The technology worked," Dave McMahon VP of Marketing for Luminous told Medical Device Daily. "We went and met with the FDA over a year ago about the device. The outcome was that [FDA] said this is technology that they weren't sure how to evaluate. They also told us that if we went that route it was going to be a pretty large clinical trial that was needed to show efficacy of the device. The bottom line was that we could go ahead and file the device for a 510(k) application but it sounded like we would have had to take the PMA route and a PMA wasn't in our timeline. Fortunately for us we had a backup plan."
That plan included a deal with a major supplier (that the company hasn't yet revealed) of electrochemical sensors for exclusive rights to incorporate its glucose sensor into Luminous' automated blood glucose monitor. This sensor has already been FDA-approved and would put Luminous in a better position to get its entire product approved. As of press time the company had not settled on a name for the device.
"It was not an easy decision for us to make," McMahon said. "The company was founded on this technology.
Luminous said that it is preparing for pivotal clinical trials and a 510(k) application in 2010. If the company has favorable results in trials and gets an FDA approval, it plans to launch the device at the end of 2010.
Glucose oxidase electrochemistry has been used to measure glucose with near laboratory accuracy in point-of-care devices for many years. The FDA has recently expressed concern about the use of test strip-based glucose meters that are not cleared to manage glucose in hospitalized patients. The Luminous product is being designed to automate the process of glucose monitoring while simultaneously raising the bar for measurement accuracy at the point of care.
And it has had significant support in funding to do so.
Last year Luminous reported completing a $23.5 million round Series B financing. Adams Street Partners led the investment, joined by new investors RiverVest Venture Partners, and Finistere Ventures. Existing investors De Novo Ventures and Latterell Venture Partners also participated in the round (Medical Device Daily, March 19, 2008).
The company previously completed a $9 million round of Series A funding in 2005.
"We're seeking a Series C round in 1Q10 to get us onto the market," McMahon told MDD.
To further garner support for the device Luminous will be displaying it at the Society of Critical Care Medicine's (Mount Prospect, Illinois) Post-Congress Conference to be held in Key West, Florida from January 13th January 15th, 2010.
If successful the company could become a huge player in a market with a strong clinical demand for glycemic control. To date, multiple clinical studies have demonstrated significant morbidity and mortality benefits from controlling glucose levels in critical care patients. As a result, clinicians have rapidly adopted glycemic control procedures but struggle with inadequate and time consuming manual methods.
The device would eliminate these time consuming methods and eliminate a lot of human error introduced into the process the company says.
Omar Ford, 404-262-5546;